Pixantrone: a new agent for relapsed aggressive lymphomas
Mené dans 66 hôpitaux sur 140 patients atteints d'un lymphome non hodgkinien agressif, réfractaire ou récidivant, cet essai international évalue l'efficacité et la toxicité du pixantrone en traitement de rattrapage
Pixantrone, an anthracycline with a novel chemical structure, was synthesised about 20 years ago to provide similar antitumour activity to the anthracyclines, but without the cardiotoxicity. In March 22, 2010, the drug underwent review by the Oncologic Drugs Advisory Committee of the US Food and Drug Administration (FDA), and was promptly rejected. In spite of the FDA's rejection in the USA, the European Medicines Agency (EMA) granted the drug approval in February, 2012, on the condition that additional data for patients who had previously received rituximab be provided in the future. Now that the storm has passed—2 years after the controversial FDA rejection and a few months after EMA's conditional approval—the full results of the study have been published in The Lancet Oncology.
The Lancet Oncology , commentaire en libre accès, 2011